Evusheld Likely Not Effective Against Omicron, FDA Says

The FDA has updated its fact sheet for healthcare providers for the use of AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) which is authorized for emergency use for treatment of COVID-19 infections.

The agency warned that the injectable treatment might not be able to neutralize certain SARS-CoV-2 viral variants and that Evusheld might not be effective at preventing COVID-19 caused by the variants.

Of particular concern is the BA.4.6 form of Omicron, which has shown reduced susceptibility to the drug.

Evusheld is currently authorized for the pre-exposure prophylaxis of COVID-19 in adults and pediatric individuals 12 years of age and older weighing at least 40 kilograms (88 pounds).